Compliant Quality Management System in Confluence by Multiple Vendors

Think the Atlassian galaxy is home to only modern software-driven enterprises? You will be surprised that even teams from the most regulated industries like automotive, aerospace, or medical devices can grow on this soil. These companies are often challenged by strict regulatory requirements under ISO, CE, or the FDA. Confluence enables them to strike the perfect balance between compliance management and a collaborative work environment within the vast project management space.

The answer to compliance challenges lies in a Confluence-based Quality Management System (QMS). At its core, a QMS documents organization-wide processes procedures, results, and duties. Traditional paper-based systems can’t cut it anymore. The evolving modern workplace demands a solid QMS where teams, internal members, and external auditors alike, can access information and collaborate in real-time.

Each industry has standard criteria for compliance. In general, the major bottlenecks in using a traditional QMS include:

  • Documents must be persistent and easily accessible.
  • Documents must show verified approvals.
  • A complete archive of all documentation must remain available.

Confluence offers an intuitive platform for project managers to control documents. Coupled with powerful apps available in the Atlassian Marketplace, businesses can extend Confluence to implement a compliant QMS. For example, medical device software companies adhere to rigid standard procedures through the Comala Document Management and SoftComply eQMS apps.

Comala Document Management Adds Verified Approvals and Access Control Comala Document Management can help teams stay compliant with FDA and ISO requirements by implementing reviews and approvals in Confluence. Using Document Management, managers can track the documents throughout mandatory review phases, as well as role-based approvals.

Being able to grant access permissions is the first critical step to compliance, including restrictions on permanent deletion of documents and decommissioning of records in a workflow. In addition to these controls, the app also maintains the validation procedures by keeping the archived QMS documents associated with audit trails for as long as needed. It makes this possible by adjusting page permissions when necessary while logging all approval and review information inside the Confluence Audit Log.

SoftComply eQMS Jumpstarts QMS Implementation Medical device software providers use Comala Document Management in combination with SoftComply eQMS to bring their teams up to speed. With fully customizable space and prefilled document templates based on ISO 13485, IEC 62304 & 21 CFR 820, SoftComply offers an optimal QMS for medical devices following industry best practices. It fulfills the following qualities.

  • Simple - Maintain a limited number of procedures and templates to ensure compliance without excessive paperwork overburdening a company. The FDA refers to this as the “least burdensome approach,” and quality over quantity.
  • Usable - Procedures are written to be understood by average users, meaning no regulatory jargon. The documents in the SoftComply eQMS were created with day to-day use in mind.
  • Embedded - It’s best to use a QMS that integrates nicely with existing IT infrastructure, like how Confluence integrates with Jira.

With a scalable Quality Management System in Confluence, teams can seamlessly maneuver complex standard operating procedures and replicate technical templates across multiple pages. Developers can then copy the required templates to any product development project space within Confluence and customize them for individual project specifications.

The integration of regulatory compliance into software development is not only desirable but, in many cases, mandatory. Atlassian tools provide a valuable link between the rapid software development environment and the exoplanet of regulatory compliance. Supported by a cornucopia of apps available on the Atlassian Marketplace, Confluence is undoubtedly a popular choice for quality management purposes in the healthcare, software, and finance spaces, to name a few.